Flatiron Health Adds End-to-End Services to RWE Offerings

May 16th, 2023|Categories: Featured, Industry News|Tags: , |

Flatiron Health has announced the addition of new end-to-end services for oncology real-world evidence (RWE) generation and analysis to its real-world data (RWD) offerings. The new services are available through Flatiron’s OncoEMR® platform and are intended to help accelerate oncology research with human expertise and machine learning techniques.

Real-World Evidence Study Supports Efficacy of Monoclonal Antibody for Infant RSV

May 15th, 2023|Categories: Featured, Industry News|Tags: , |

Real-world evidence (RWE) presented at this year’s European Society for Paediatric Infectious Diseases meeting show that administration of nirsevimab, a monoclonal antibody (mAb), prevented hospitalizations in infants infected with respiratory syncytial virus (RSV). Data from over 8,000 babies was taken from the 2022-2023 RSV season.

Real-World Evidence Backs Venetoclax-Based Treatment in Chronic Lymphocytic Lymphoma

May 11th, 2023|Categories: Featured, Industry News|Tags: , , |

A real-world evidence (RWE) study presented at this year’s ISPOR meeting shows that venetoclax-based treatment regimens improve patient outcomes in chronic lymphocytic lymphoma (CLL). Patients on venetoclax (Venclexta) had reduced rates of treatment initiation and had a longer time before new treatments or death. The study was based off electronic health records (EHR) from CLL patients across the US.

Real-World Data Study Finds Sickle Cell Decreases Life Expectancy by 32 Years in Brazil

May 10th, 2023|Categories: Featured, Industry News|Tags: , , , |

A recently published real-world data (RWD) study in Blood Advances found that sickle cell disease (SCD) is associated with a 32 year decrease in life expectancy in Brazil. SCD has a significant impact on health outcomes worldwide, causing a 22-year drop in the US, for example. This study examined healthcare data collected between 2015 and 2019.

Responding to Next Public Health Emergency With Real-World Data

May 5th, 2023|Categories: Featured, Industry News|Tags: , , |

The COVID-19 pandemic spurred a sea change in the real-world data (RWD) landscape, bolstering its utilization and recognition. Eventually, another public health crisis will emerge, and by continuing to support the development of RWD resources and utilization, we can rise to the challenge even more quickly. Learn more about how The MITRE Corporation helped during the pandemic and how it is planning for the next public health emergency.

How to Overcome Challenges When Backing Regulatory Submissions with Real-World Data

May 5th, 2023|Categories: Featured, Industry News|Tags: , , |

Clinical developers and regulatory approval agencies are increasingly relying on real-world data (RWD) and the real-world evidence (RWE) generated from it in decision-making. However, clinical research organizations (CROs) often run into significant pitfalls when using RWD, complicating the process and driving up expenses. In a new Applied Clinical Trials article, learn what these challenges are and how to overcome them.

Inspire RWE Launched to Empower Patient-Centered Healthcare Research

May 4th, 2023|Categories: Featured, Industry News|Tags: , |

Inspire has launched its new real-world evidence (RWE) platform Inspire RWE. The platform provides research organizations with a large pool of patient-reported real-world data (RWD) and powerful analytical tools to drive evidence generation that focuses on patients and their healthcare experiences to advance patient-centered care.

FDA Guidance on RWD and Externally Controlled Trials Leaves Stakeholders Confused

May 4th, 2023|Categories: Featured, Industry News|Tags: , |

A recent draft guidance by the US Food and Drug Administration (FDA) on the use of real-world data (RWD) and externally controlled trials has many stakeholders asking for further clarification on several key points. In particular, many left public comments asking for specific examples of how handle issues when using real-world evidence (RWE).

Flatiron Showcases Oncology Real-World Data at ISPOR 2023

May 4th, 2023|Categories: Featured, Industry News|Tags: , |

Experts from Flatiron Health will share the latest in oncology real-world data (RWD) research at this year’s ISPOR 2023 Conference in 10 presentations and 6 posters. The presenters will discuss how RWD and real-world evidence (RWE) are changing the oncology landscape. One poster presentation will show how characteristics of different practices affects multiple myeloma outfcomes, while the other investigates the effects of racism on metastatic breast cancer patient outcomes.

PRMA Launches MALCOM HEOR and Market Access E-Learning Platform

May 4th, 2023|Categories: Featured, HEOR Feature, Industry News|Tags: , |

Health economics and outcomes research (HEOR) and market access experts require in-depth knowledge and a finger on the pulse of the latest trends to keep up in this constantly shifting field. To this goal, PRMA Consulting has launched the Market Access Learning Compendium (MALCOM), an e-learning platform packed with educational resources that cover all aspects of HEOR and market access, from core concepts to industry-shaping current events.

Using Real-World Evidence to Advance Geometric Atrophy Care

April 28th, 2023|Categories: Featured, Industry News|Tags: , , |

Despite advances in treating geometric atrophy (GA), a progressive eye disorder, patient responses to treatment are variable. In a new interview with AJMC, Ashard Khanani, MD, talks about how real-world evidence (RWE) can help advance GA care by revealing the real-world impact of treatments on patient health outcomes.

Study Shows Real-World Evidence Studies Produce Similar Results to RCTs

April 26th, 2023|Categories: Featured, Industry News|Tags: , |

A newly published study in JAMA finds that real-world evidence (RWE) studies produce similar results to randomized clinical trials (RCTs). The researchers analyzed 32 RCTs and created protocols for RWE studies that mirror them using the Aetion Evidence Platform (AEP). Analysis of the mirror studies showed that RWE study outcomes reached the same conclusion half of the time.

Examining How Real-World Data Can Advance Health Equity

April 20th, 2023|Categories: Featured, Industry News|Tags: , |

Although randomized controlled trials (RCTs) are considered the gold standard for drug development and clinical research, real-world data (RWD) is increasingly being used to accelerate research and regulatory approval. In addition, RWD and the real-world evidence generated from it have great potential to advance health equity.

Breaking Down International Regulators’ Thoughts on AI and Real-World Evidence

April 19th, 2023|Categories: Featured, Industry News|Tags: , |

A newly published paper in Regulatory Toxicology and Pharmacology explores insights shared by an international group of regulators at the 2021 Global Summit on Regulatory Science. The group consisted of regulators from the US, the UK, India, Japan, Italy, Germany, Canada, Singapore, Brazil, and Switzerland. During the talks, speakers discussed ways to use artificial intelligence (AI) and real-world evidence (RWE) in safety assessments for food and drugs.

Real-World Evidence Study Finds Cefiderocol Effective Against Antibiotic-Resistant Bacterial Infections

April 17th, 2023|Categories: Featured, Industry News|Tags: , , , |

Shionogi & Co., Ltd. will present real-world evidence (RWE) showing that its antibiotic Fetcroja (cediferocol) is effective at treating infections caused by antimicrobial-resistant Gram-negative bacteria. The results, which will be shared at this week at the European Congress of Clinical Microbiology & Infectious Diseases.

Real-World Evidence Studies Find Remdesivir Effective for Immunocompromised Patients with COVID-19

April 17th, 2023|Categories: Featured, Industry News|Tags: , |

Gilead Sciences, manufacturers of Remdesivir, announced results from 2 real-world evidence (RWE) studies demonstrating the efficacy and safety of the drug in immunocompromised patients with COVID-19. The first study showed that the anti-viral medication reduced mortality significantly in patients living with cancer and all previous variants of COVID-19.

Verantos Announces Launch of Real-World Evidence Generation Tool Pragmatic Registry

April 12th, 2023|Categories: Featured, Industry News|Tags: |

Verantos has launched Pragmatic Registry, its new real-world evidence (RWE) generation tool. Pragmatic Registry, operating on the Verantos Evidence Platform, contains a wealth of real-world data (RWD) that users can leverage to generate high-validity RWE, which is highly valued by payers, providers, and regulatory bodies.

Canada’s PAAB Releases Draft Guidance on Pharma Advertising Based on Real-World Evidence

April 5th, 2023|Categories: Featured, Industry News|Tags: , |

The Canadian not-for-profit Pharmaceutical Advertising Advisory Board (PAAB) has just released a draft guidance covering pharma advertising to healthcare professionals (HCPs) based on real-world evidence (RWE). The guidance provides direction on assessing the validity and importance of RWE and the real-world data (RWD) it is derived from when making advertising decisions.

Reducing the Financial Impact of Tuberculosis in India

April 4th, 2023|Categories: Featured, Industry News|Tags: , , , |

Despite concerted efforts like the END TB Strategy, India faces the highest disease and economic burden for tuberculosis. A newly published study in PLOS Global Public Health, explores the financial burden and consequences for patients with TB in the nation. Regardless of the free diagnostic and treatment provided by the state, patients spent significant funds on care.

Darwin EU Seeks New Partnerships After Successful First Year

March 29th, 2023|Categories: Featured, HEOR Feature, Industry News|Tags: , , |

The European Medicines Agency (EMA) has issued a call for applications for new partnerships with Darwin EU. The move comes after a successful first year that saw the implementation of four real-world data (RWD) projects that investigated rare blood cancers, the use of certain medications tied to pregnancy issues, antibiotic prescription patterns, and severe asthma.

Cancer Moonshot Goes Digital with CancerX Partnership

March 29th, 2023|Categories: Featured, Industry News|Tags: , |

The next move in the Biden Administration’s Cancer Moonshot is digital. The CancerX program, proposed in February, is a public-private partnership between the Digital Medicine Society (DiMe) and the Moffit Cancer Center that is focused on accelerating digital projects in oncology. Key initiatives include evidence generation, toolkit development, and best practice recommendations.

Improving Image Guided Therapy with Real-World Data

March 28th, 2023|Categories: Featured, Industry News|Tags: , |

Image-guided therapies improve health outcomes for patients, but greater pools of data are needed to support future development. Real-world data (RWD) can be used to provide a wealth of data related to image-guided therapies, supplementing classic randomized clinical trials (RCTs) and improving understanding and clinical application. Learn more about how RWD is crucial for advancing these therapies in a new article from Bert van Meurs of Phillips.

The Growing Impact of Health Economics

March 28th, 2023|Categories: Featured, Industry News|Tags: , , |

The field of health economics has existed for decades but has been brought to new prominence with recent policy decisions and the COVID-19 pandemic. In a new Health Tech Zone article, learn about the basics of health economics, how different stakeholders are leveraging it, and the growing impact the field has on the US healthcare system.

Real-World Evidence Explores Inpatient and Outpatient Delivery of CAR T-Cell Therapy

March 23rd, 2023|Categories: Featured, Industry News|Tags: , , , |

Real-world evidence (RWE) presented at the 2023 Transplantation and Cellular Therapy Meeting compared and contrasted outcomes for patients receiving inpatient vs. outpatient CAR T-cell therapy for mantle cell lymphoma (MCL) and follicular lymphoma (FL). Patients with FL fared better with outpatient treatment, but those fighting MCL had slightly more adverse events (AEs) with outpatient infusions.

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